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Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy

AbbVie
Posted Jul 09
Full Time
North Chicago, Illinois

Company Description

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn.

Job Description

The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.

  • Responsible for leading the Global Regulatory Product Team (GRPT), developing, and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.
  • Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers.
  • May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary regulatory interface with AST and supporting teams.
  • Manages compounds through all phases of development, including post approval and throughout the life cycle of the product.
  • Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.

Qualifications

  • Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
  • Required Experience: 5- 7+ years regulatory and drug development experience.
  • Proven 5+ years in a strategic leadership role with strong project management skills.
  • Preferred Experience: 7-10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan.
  • Location: Preferred location is Lake County, IL

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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